RCR Workshop – February 22, 2020Jeffrey A. Potteiger, RIO

Dylan Thompson, ORCI

Session overview

Clarification of research misconduct and research noncompliance

Case studies of research misconduct

Case studies of research noncompliance

Investigations of research noncompliance

Misconduct vs noncomplianceWhat is the difference?

Research Misconduct

Fabrication

Falsification

Plagiarism

Research Noncompliance

Failure to comply with applicable federal regulations, state or local laws, the requirements or determinations of the IRB, IACUC, or university policy for research involving human or animal subjects

Who is involved?

Principle investigator (PI) and any member of the research team

Office of Research Compliance and Integrity (ORCI)

Human Research Institutional Review Board (IRB)

Institutional Animal Care and Use Committee (IACUC)

Radiation Safety, Biosafety, Laser Safety Committees

Research Integrity Officer (RIO)

DHHS – Office of Research Integrity (ORI)

DHHS – Office for Human Research Protections (OHRP)

Funding agencies – NIH, NSF, FDA, etc.

Research misconduct at GVSU

Research misconduct is defined in GVSU policies as the fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results, and/or engaging in ordering, advising or suggesting that subordinates engage in misconduct in research, scholarship or creative activities. Research misconduct does not include honest error or differences of opinion. This policy does not cover authorship disputes unless they involve plagiarism.

Financial costs and personal consequences of research misconduct resulting in retracted publications. Stern et al. eLife 2014;3:e02956

Research misconduct and noncompliance

Office of Human Research Protections

https://www.hhs.gov/ohrp/

Office of Research Integrity

https://ori.hhs.gov/case_summary

Michael LaCour – Political Science

Researched the influence of gay canvassers on political opinions Contradicted current literature that suggested no influence Resulted in job offer from Princeton University

Replication study First issue – The study surveyed 10,000 individuals Second issue – uSamp survey group had no record of LaCour Third issue – Identified data as stolen from Corporate

Campaign analysis project with further manipulations

LaCour’s publication was retracted and further evidence of plagiarism and falsification were identified within the study, applications, grants, and awards. https://www.vox.com/2015/6/3/8720975/science-fraud-

replication

Brian Wansink – Food Marketing

Investigations by Cornell University identified multiple instances of misconduct

Misreporting data

Improper statistical analysis

Incorrect documentation and retention of research data

Inappropriate authorship

Wansink had 15 papers retracted and resigned from Cornell

https://www.vox.com/science-and-health/2018/9/19/17879102/brian-wansink-cornell-food-brand-lab-retractions-jama

Discussion - Identifying Misconduct

Jerry had written a very similar introduction to his article from 12 years prior, for a soon to be published paper.

Jerry realized his problem and cited the prior article, is this still an issue?

Sandy was tasked with surveying 100 random students. She decided to find similar results online in accordance with her hypothesis.

Sam had photoshopped a crowd around an advertisement being researched and published the figure with his paper.

Jane was recording the results from a survey that had questions which prompted participants to answer with a 1-10 response. Jane got half-way through (500/1000) samples and decided to apply the average of the first half of the sample to the whole sample.

Plagiarism Expanded

Mavrogenis, Andreas F., et al. “Scientific Misconduct (Fraud) in Medical Writing.” Orthopedics, vol. 41, no. 2, 29 2018, pp.

e176–e181., doi:10.3928/01477447-20180123-06.

References

Lin, Darrin. “Research Misconduct Cases.” Examples of Research Misconduct - Research Integrity Officer (RIO) - Baruch College, Baruch College, 25 Jan. 2016, www.baruch.cuny.edu/rio/research_misconduct_examples.htm.

Oransky, Ivan. “Cornell Finds That Food Marketing Researcher Brian Wansink Committed Misconduct, as He Announces Retirement.” Retraction Watch, 21 Sept. 2018, retractionwatch.com/2018/09/20/beleaguered-food-marketing-researcher-brian-wansink-announces-his-retirement-from-cornell/.

Mavrogenis, Andreas F., et al. “Scientific Misconduct (Fraud) in Medical Writing.” Orthopedics, vol. 41, no. 2, 29 2018, pp. e176–e181., doi:10.3928/01477447-20180123-06.

Research noncompliance

Serious

Continuing

Categories are important for reporting purposes

Non-serious or minor noncompliance

Noncompliance that does not increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human research protection program

Serious noncompliance

Noncompliance that increases risk to research participants, compromises participants’ rights or welfare, or affects the integrity of the research/data or the human research protection program

Continuing noncompliance

Noncompliance (serious or non-serious) that has been previously reported, or a pattern of ongoing activities that indicate a lack of understanding of human subjects protection requirements that may affect research participants or the validity of the research and suggest the potential for future noncompliance without intervention

Examples of noncompliance

Failure to obtain IRB/IACUC approval prior to conducting human/animal subjects research

Continuation of research activities after a study has expired

Failure to obtain informed consent of research subjects

Failure to obtain the date informed consent was obtained from research subjects enrolled in a study

Inappropriate oversight of the research to ensure the safety of human/animal subjects and the integrity of the research/data

Examples of noncompliance

Failure to follow research procedures as outlined in the protocol/research plan reviewed and approved by the IRB/IACUC

Implementation of changes in research procedures or a revised informed consent document prior to IRB/IACUC approval

Implementation of a new survey or survey question prior to IRB approval

Examples of noncompliance

The occurrence of the same deviation (on multiple occasions) from the approved protocol without submission of an amendment to change study procedures

Failure to obtain informed consent on more than one subject

Any establishment of a pattern of behavior which results in noncompliance

Case study noncompliance

The IRB chairperson learns of a project that involved retrospective review of patient’s clinical data for purposes of drawing conclusions about the efficacy of an a certain drug intervention

The PI did not ask the IRB about the need for review before starting the project

Is this covered human subjects research – why or why not?

Case study noncompliance

The IRB chairperson learns of a project that involved retrospective review of patient’s clinical data for purposes of drawing conclusions about the efficacy of an a certain drug intervention

The PI did not ask the IRB about the need for review before starting the project

The activity should have been considered research and received IRB review

It aimed to draw generalizable conclusions

It involved human subjects by way of identifiable information

Case study noncompliance

An unanticipated problem was identified in a study protocol of older adults in an assisted-care facility

The PI informed the subjects about the new risk and reported the unanticipated problem to the IRB within 5 days

Is this research noncompliance – why or why not?

Case study noncompliance

An unanticipated problem was identified in a study protocol of older adults in an assisted-care facility

The PI informed the subjects about the new risk and reported the unanticipated problem to the IRB within 5 days

This is research is in compliance as unanticipated problems must be reported to the IRB within 7 days of learning of the problem

Case study noncompliance

A study team evaluates a change in class meeting time on the academic performance of students in a local school

Academic performance by teacher by grade is evaluated

The PI did not collect informed consent

Is this research noncompliance – why or why not?

Case study noncompliance

A study team evaluates a change in class meeting time on the academic performance of students in a local school

Academic performance by teacher by grade is evaluated

The PI did not collect informed consent

This is considered program evaluation and not covered human subjects research

Case study noncompliance

A PI learns that the mice in her study did not get food or water for 2 weekend days

The PI provided food and water on Monday and immediately reported the incident to the Chairperson of the IACUC

Is this research noncompliance?

Case study noncompliance

A PI learns that the mice in her study did not get food or water for 2 weekend days

The PI provided food and water on Monday and immediately reported the incident to the Chairperson of the IACUC

This is research noncompliance as vertebrate animals must be provided with care every day

Investigations of noncompliance

Reports of noncompliance are addressed by the ORCI, IRB Chairperson, and RIO

After initial fact finding, an inquiry may be conducted by ORCI to further evaluate the noncompliance

A report is prepared by the ORCI, and reviewed by the IRB Chairperson and the RIO for noncompliance and administrative actions are taken if necessary

If serious or continuing and federally funded, a letter must be sent to OHRP. If FDA regulated, a letter must be sent to FDA. If externally funded, a letter must be sent to the sponsor.

Administrative actions

Notification of research subjects or re-consent of current research subjects

Modifications to the protocol or informed consent document

Periodic monitoring by the ORCI

Use of data disallowed or conditions attached

Suspension of funding accounts

Suspension or termination of research

Suspending the privileges of a PI to conduct human subjects research

Questions?